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Home > "E" Clinical Trials Conditions > Effects of Therapeutic HIV Vaccination on Control of HIV after Discontinuation of Anti-HIV Drugs  Effects of Therapeutic HIV Vaccination on Control of HIV after Discontinuation of Anti-HIV Drugs
Effects of Therapeutic HIV Vaccination on Control of HIV after Discontinuation of Anti-HIV Drugs
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The purpose of this study is to determine whether therapeutic HIV vaccines can help the immune system control HIV viral load after anti-HIV drugs are discontinued.
Details: This study is a rollover study for patients who participated in A5058s: Augmentation of HIV-Specific Helper and CTL Responses Through Therapeutic Vaccination in Individuals Receiving Potent Suppressive Antiretroviral Therapies. In A5058s, patients received a series of therapeutic vaccinations to elicit HIV-specific immune responses. This study will examine whether these vaccine-induced responses can control viral load in the absence of antiretroviral therapy (ART). Upon study entry, patients will discontinue ART. During the first 6 weeks of the study, viral load will be monitored weekly and CD4+ T-cell counts will be monitored every other week. Viral load and CD4+ T-cell counts will be measured every other week from Week 6 through Week 24, then monthly until patients restart ART or until Week 48. Patients who reinitiate ART for any reason will be registered to Step 2 and followed for 10 weeks.
Eligibility:
Study Type: Observational, Screening, Longitudinal, Defined Population, Prospective Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Participation in A5058s and receipt of a minimum of 7 sets of injections on that study - Continuation of the same stable antiretroviral treatment that was given in A5058s for the last 3 months prior to A5172 entry, unless the regimen was changed for toxicity in the absence of virologic failure - No less than 6 weeks and no more than 18 weeks since the last injection on A5058s prior to A5172 entry - CD4+ T-cell count > 300 cells/mm3 obtained within 30 days prior to study entry - HIV-1 RNA < 500 copies/ml obtained within 30 days prior to study entry - Agreement to use approved methods of contraception Exclusion Criteria: - Pregnancy or breast-feeding - Any of the following within 30 days prior to entry: acute infection requiring antibiotics, outbreak of herpes simplex virus (HSV) or herpes zoster, other acute medical illness, or surgery - Symptomatic chronic infections other than HIV - Malignancy that may require systemic therapy - History of lymph node irradiation - Use of immunoenhancing or immunosuppressive drugs within 30 days prior to entry, or any underlying disease of sufficient severity that these excluded drugs may be prescribed - Hydroxyurea within 30 days prior to study entry - Use of GM-CSF, G-CSF, M-CSF, IFN, IL-2, or other cytokines within 30 days prior to study entry - Active drug or alcohol use or dependence that would interfere with adherence to study requirements - Serious illness requiring systemic treatment and/or hospitalization until patient either completes therapy or is clinically stable on therapy for at least 30 days prior to study entry
Total Enrollment: 78
Location and Contact Information:
Overall Study Official:
FredValentine, Study Chair, NYU Medical Center
Beth Israel Med Ctr
New York City, New York, 10003
United States
NYU/Bellevue
New York City, New York, 10016-6481
United States
Boston Med Ctr (Harvard)
Boston, Massachusetts, 02118
United States
Wishard Hosp
Indianapolis, Indiana, 46202
United States
Univ of Colorado Health Sciences Ctr, Denver
Denver, Colorado, 80262
United States
Univ of Texas, Galveston
Galveston, Texas, 77555
United States
Beth Israel Deaconess- West Campus
Boston, Massachusetts, 02215
United States
Indiana Univ Hosp
Indianapolis, Indiana, 46202
United States
Brigham and Womens Hosp
Boston, Massachusetts, 02215
United States
Case Western Reserve Univ
Cleveland, Ohio, 44106-5083
United States
Harvard (Massachusetts General Hosp)
Boston, Massachusetts, 02114
United States
Univ of North Carolina
Chapel Hill, North Carolina, 27514
United States
Methodist Hosp of Indiana
Indianapolis, Indiana, 46202
United States
Harbor General/UCLA
Torrance, California, 90502-2052
United States
Additional Information:
Study ID Numbers: ACTG A5172;
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00050063
Other Hiv Infections Studies:
1. A Study of Dideoxycytidine Plus Zidovudine in the Treatment of AIDS or Advanced AIDS Related Complex (ARC)
2. A Study to Evaluate the Effects of Giving Interleukin-2 (IL-2) Plus Anti-HIV Therapy to HIV-Positive Patients with CD4 Cell Counts of at Least 350 Cells/mm3
3. A Study of Cidofovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients with AIDS
4. A Randomized Controlled Prophylactic Study of Clofazimine To Prevent Mycobacterium Avium Complex Infection in HIV Disease
5. Photodynamic Therapy Clinical Trial For Cutaneous AIDS-Related Kaposi's Sarcoma Study Summary.
Related Studies:
Other HIV Infections Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
Effects of Therapeutic HIV Vaccination on Control of HIV after Discontinuation of Anti-HIV Drugs
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